NCT02951260

Brief Summary

The purpose of this study is to evaluate the potential interaction between metformin and exercise in order to optimize clinical guidelines for treatment of T2D.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

October 27, 2016

Last Update Submit

September 26, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Overall aerobic work performed during an exercise bout with self-selected intensity

    Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity

Secondary Outcomes (6)

  • External work performed during an exercise bout with self-selected intensity

    Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity

  • Rate of perceived exertion during an exercise bout with fixed intensity

    Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity

  • blood lactate during an exercise bout with fixed intensity

    Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity

  • Heartrate during an exercise bout with fixed intensity

    Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity

  • Respiratory exchange ratio during an exercise bout with fixed intensity

    Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity

  • +1 more secondary outcomes

Other Outcomes (2)

  • AMPK-activation in skeletal muscle during an exercise bout with fixed intensity

    change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity

  • Oxidative phosphorylation in skeletal muscle fibers

    Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment

Study Arms (2)

Metformin

EXPERIMENTAL

17 days metformin treatment

Drug: Metformin

Placebo

PLACEBO COMPARATOR

17 days placebo treatment

Other: Placebo

Interventions

MetforminDRUG

17 days treatment with metformin

Metformin
PlaceboOTHER

17 days treatment with placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • HbA1c \< 39 mmol/l
  • BMI \< 25
  • structured physical activity \< = 150 min/week
  • apparently healthy

You may not qualify if:

  • smoking
  • daily pharmaceutical treatment
  • contraindication to increased levels of physical activity
  • ALAT/ASAT elevated 3 times above upper normal values
  • renal insufficiency (eGFR \< 60 ml/min)
  • prior history of lactic acidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for aktiv sundhed

Copenhagen, Copenhagen N, 2200, Denmark

Location

Related Publications (1)

  • Pilmark NS, Oberholzer L, Halling JF, Kristensen JM, Bonding CP, Elkjaer I, Lyngbaek M, Elster G, Siebenmann C, Holm NFR, Birk JB, Larsen EL, Lundby AM, Wojtaszewski J, Pilegaard H, Poulsen HE, Pedersen BK, Hansen KB, Karstoft K. Skeletal muscle adaptations to exercise are not influenced by metformin treatment in humans: secondary analyses of 2 randomized, clinical trials. Appl Physiol Nutr Metab. 2022 Mar;47(3):309-320. doi: 10.1139/apnm-2021-0194. Epub 2021 Nov 16.

    PMID: 34784247DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Kristian Karstoft, MD, PhD

    Center for aktiv sundhed, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

September 27, 2017

Record last verified: 2017-09

Locations

DK(1)